Biopsy device with replaceable probe incorporating static vacuum source dual valve sample stacking retrieval and saline flush

ABSTRACT

A biopsy device and method are provided for obtaining a tissue sample, such as a breast tissue biopsy sample. The biopsy device includes a disposable probe assembly with an outer cannula having a distal piercing tip, a cutter lumen, and a cutter tube that rotates and translates past a side aperture in the outer cannula to sever a tissue sample. The biopsy device also includes a reusable hand piece with an integral motor and power source to make a convenient, untethered control for use with ultrasonic imaging. The reusable hand piece incorporates a probe oscillation mode to assist when inserting the distal piercing tip into tissue. A saline valve positioned by the reusable hand piece communicates a saline supply through the probe assembly to perform saline flush of the cutter tube and outer cannula.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is related to the co-pending and commonly-ownedU.S. patent application Ser. No. 11/198,558 “BIOPSY DEVICE WITHREPLACEABLE PROBE AND INCORPORATING VIBRATION INSERTION ASSIST ANDSTATIC VACUUM SOURCE SAMPLE STACKING RETRIEVAL” to Hibner et al., filed8 Aug. 2005, the disclosure of which is hereby incorporated by referencein its entirety.

FIELD OF THE INVENTION

The present invention relates in general to biopsy devices, and moreparticularly to biopsy devices having a cutter for severing tissue, andeven more particularly to biopsy devices for multiple sampling with aprobe remaining inserted.

BACKGROUND OF THE INVENTION

When a suspicious tissue mass is discovered in a patient's breastthrough examination, ultrasound, MRI, X-ray imaging or the like, it isoften necessary to perform a biopsy procedure to remove one or moresamples of that tissue in order to determine whether the mass containscancerous cells. A biopsy may be performed using an open or percutaneousmethod.

An open biopsy is performed by making a large incision in the breast andremoving either the entire mass, called an excisional biopsy, or asubstantial portion of it, known as an incisional biopsy. An open biopsyis a surgical procedure that is usually done as an outpatient procedurein a hospital or a surgical center, involving both high cost and a highlevel of trauma to the patient. Open biopsy carries a relatively higherrisk of infection and bleeding than does percutaneous biopsy, and thedisfigurement that sometimes results from an open biopsy may make itdifficult to read future mammograms. Further, the aestheticconsiderations of the patient make open biopsy even less appealing dueto the risk of disfigurement. Given that a high percentage of biopsiesshow that the suspicious tissue mass is not cancerous, the downsides ofthe open biopsy procedure render this method inappropriate in manycases.

Percutaneous biopsy, to the contrary, is much less invasive than openbiopsy. Percutaneous biopsy may be performed using fine needleaspiration (FNA) or core needle biopsy. In FNA, a very thin needle isused to withdraw fluid and cells from the suspicious tissue mass. Thismethod has an advantage in that it is very low-pain, so low-pain thatlocal anesthetic is not always used because the application of it may bemore painful than the FNA itself. However, a shortcoming of FNA is thatonly a small number of cells are obtained through the procedure,rendering it relatively less useful in analyzing the suspicious tissueand making an assessment of the progression of the cancer less simple ifthe sample is found to be malignant.

During a core needle biopsy, a small tissue sample is removed allowingfor a pathological assessment of the tissue, including an assessment ofthe progression of any cancerous cells that are found. The followingpatent documents disclose various core biopsy devices and areincorporated herein by reference in their entirety: U.S. Pat. No.6,273,862 issued Aug. 14, 2001; U.S. Pat. No. 6,231,522 issued May 15,2001; U.S. Pat. No. 6,228,055 issued May 8, 2001; U.S. Pat. No.6,120,462 issued Sep. 19, 2000; U.S. Pat. No. 6,086,544 issued Jul. 11,2000; U.S. Pat. No. 6,077,230 issued Jun. 20, 2000; U.S. Pat. No.6,017,316 issued Jan. 25, 2000; U.S. Pat. No. 6,007,497 issued Dec. 28,1999; U.S. Pat. No. 5,980,469 issued Nov. 9, 1999; U.S. Pat. No.5,964,716 issued Oct. 12, 1999; U.S. Pat. No. 5,928,164 issued Jul. 27,1999; U.S. Pat. No. 5,775,333 issued Jul. 7, 1998; U.S. Pat. No.5,769,086 issued Jun. 23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22,1997; U.S. Pat. No. 5,526,822 issued Jun. 18, 1996; and US PatentApplication 2003/0199753 published Oct. 23, 2003 to Hibner et al.

At present, a biopsy instrument marketed under the tradename MAMMOTOMEis commercially available from ETHICON ENDO-SURGERY, INC. for use inobtaining breast biopsy samples. These devices generally retrievemultiple core biopsy samples from one insertion into breast tissue withvacuum assistance. In particular, a cutter tube is extended into a probeto cut tissue prolapsed into a side aperture under vacuum assistance andthen the cutter tube is fully retracted between cuts to extract thesample.

With a long probe, the rate of sample taking is limited not only by thetime required to rotate or reposition the probe but also by the timeneeded to translate the cutter. As an alternative to this “long stroke”biopsy device, a “short stroke” biopsy device is described in thefollowing commonly assigned patent applications: U.S. patent applicationSer. No. 10/676,944, “Biopsy Instrument with Internal SpecimenCollection Mechanism” filed Sep. 30, 2003 in the name of Hibner et al.;and U.S. patent application Ser. No. 10/732,843, “Biopsy Device withSample Tube” filed Dec. 10, 2003 in the name of Cicenas et al. Thecutter is cycled across the side aperture, reducing the sample time.Several alternative specimen collection mechanisms are described thatdraw samples through the cutter tube, all of which allow for takingmultiple samples without removing the probe from the breast.

Even given the many advantages of such multiple sample taking corebiopsy devices, in certain applications some surgeons continue to useless expensive biopsy devices guided in real time by an ultrasonicsystem. These simple biopsy systems omit a full function control consolethat operates the cutter and vacuum assistance. Instead, a manuallycontrolled hand piece advances a cutter by either stored spring force, aconstant pneumatic pressure source, or motor power. Then the surgeonactivates a cutter motor to effect the tissue sample. Thus, the surgeonis challenged to maintain the biopsy probe at a desired surgical sitewhile manipulating the patient's breast.

Spring-fired core needle biopsy devices rely upon a firing mechanismthat thrusts forward a needle and a cutter to penetrate the tissue andto obtain a tissue sample rather than prolapsing tissue into a sideaperture of a probe. Frequently, a surgeon may encounter an area ofdense tissue that is more difficult to penetrate than the surroundingtissue during core needle biopsy. In particular, the lesion or tissuemass being targeted in the biopsy procedure may be difficult topenetrate, requiring the physician to push the biopsy needle withconsiderable force and/or speed in an attempt to penetrate the lesionand collect a sample.

When encountering such an area of dense tissue, it is common forsurgeons using the type of firing core needle biopsy device describedabove to fire the device in order to penetrate the lesion and obtain asample. However, due to the length of the firing stroke of such devices,which may be as long as 0.75 inches, it is nearly impossible for thesurgeon to control the travel of the needle after firing. Consequently,the long needle stroke may cause uncertainty as to the needle tiplocation post fire. This may cause the surgeon to obtain a sample fromthe wrong area. In addition to missing the targeted tissue, long firingstrokes may cause the needle to puncture the chest wall or pierce theskin, particularly when the targeted area is near the patient's chestwall. Even if the skin is not pierced, the long travel of the needle,along with the likelihood that the needle will be pushed off course bythe force of the firing stroke, may lead to needlessly increased traumafor the patient. These spring-fired biopsy devices also yield a singlesample per insertion, thus limiting the amount of diagnostic andtherapeutic treatment that may be achieved without the increaseddiscomfort and tissue trauma from repeated insertions. Based onsurgeons' use of the long firing stroke feature of current devices toaid in penetrating tissue lesions, it is clear that the medicalcommunity sees the benefit of firing assistance when inserting a probeto the desired location.

In commonly-owned and co-pending U.S. patent application Ser. No.11/035,873, BIOPSY INSTRUMENT WITH IMPROVED NEEDLE PENETRATION toBeckman, et al., filed on Jan. 10, 2005, the disclosure of which ishereby incorporated by reference in its entirety, manual mechanisms aredisclosed that impart small reciprocating motions to the probe of a corebiopsy device to render assistance in penetrating tissue, yet cutting isperformed after the probe is properly positioned, thus avoiding takingsamples from the wrong location. Moreover, retraction of a cutter tubebetween severing samples allows for retrieval of multiple sampleswithout having to reinsert the probe through the skin again. A controlsystem that is tethered to a hand piece of this core biopsy systemprovides vacuum assistance and other motor control algorithms withnumerous clinical and safety features incorporated. Generally, the corebiopsy device portion of the system is disposable and the control systemis reused.

While these multiple sample core biopsy instruments have numerousadvantages, it is believed that the diagnostic and therapeuticopportunities of core biopsy procedures would be more widely used if aneconomical biopsy device without an elaborate control system existedwhich did not require the disposal of the entire core biopsy device.

SUMMARY OF THE INVENTION

The present invention addresses these and other problems of the priorart by providing a biopsy device that has a needle with a probe tubedefining a cutter lumen, a sample aperture formed in the probe tube, abarrier defining a first fluid passage and a second fluid passage thatboth distally-terminate at the sample aperture. A motorized mechanismaxially translates a cutter tube within the probe tube across the sampleaperture to sever tissue prolapsed therein to axially translate thecutter tube. One of the first and second fluid passages is definedwithin the cutter tube and the other is defined between an outer surfaceof the cutter tube and an inner surface of the probe tube.Advantageously, a flush valve assembly responds to a flush control andto the distally positioned cutter tube to couple either the first orsecond fluid passage to a fluid supply while the other is at a lowerpressure so that the needle is flushed. Thereby, tissue debris orcoagulated blood may be flushed so that repeated tissue samples may betaken without impediment. However, the saline flush is selectivelyemployed at the user's discretion, providing an economical reduction inthe usage of saline and a corresponding reduction in the overall size ofthe fluid collection reservoir. It is also believed that certainpathology analyses would benefit from not subjecting tissue samples to asaline flush.

In another aspect of the invention, a core biopsy device has a probeassembly with a probe support structure that holds a probe having a sideaperture. A cutter tube is slidingly received by the probe and sized totranslate across the side aperture to sever prolapsed tissue. A handpiece includes a hand piece support structure having a lateral engagingportion that receives the probe assembly. Thereby, an economicalincorporation of a replaceable probe and cutter tube into a laterallymounted assembly allows reuse of a powered hand piece, yet also providesan advantageous saline flush capability of the probe assembly.

In yet another aspect of the invention, a hand piece of a biopsy devicehas a proximal carriage that is also translated by the lead screw. Theproximal carriage selectively actuates, when the distal carriage isdistally positioned, a flush valve assembly contained in a probeassembly. A needle of the probe assembly has a cutter lumen for a cuttertube as well as a lateral lumen, both communicating with a side aperturein a probe tube. The same hand piece may instead be engaged to anotherprobe assembly that utilizes the second carriage to actuate a tissuesample retraction mechanism.

In yet a further aspect of the invention, a biopsy system includes ahand-held device that is connected to a static vacuum source and to afluid supply. The hand-held device includes a housing that is gripped toposition a core biopsy probe. Actuating user controls on the housingtranslates a motor driven cutter that translates within the core biopsyprobe to sever tissue that is prolapsed into a sample opening. Vacuumassist valve assembly in the hand-held device responds to positioning ofthe motor driven cutter to communicate static vacuum pressure from thestatic vacuum source to prolapse the tissue. Advantageously, a user mayselect to couple a fluid supply to the core biopsy probe to dispeldebris and coagulated blood.

These and other objects and advantages of the present invention shall bemade apparent from the accompanying drawings and the descriptionthereof.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the present invention, it is believed the samewill be better understood by reference to the following description,taken in conjunction with the accompanying drawings in which:

FIG. 1 is a left front isometric view from above of a biopsy device witha disposable probe assembly detached from a reusable hand piece;

FIG. 2 is a right aft isometric view from below of the biopsy device ofFIG. 1;

FIG. 3 is a right isometric view from below the disposable probeassembly of FIG. 1 disassembled to depict components of a vacuumassistance valve assembly and a saline flush valve assembly;

FIG. 4 is a longitudinal, vertical cross sectional view through a probeof the disposable probe assembly of FIG. 1;

FIG. 5 is a longitudinal, horizontal cross sectional view through avacuum assist valve assembly in an initial state (i.e., communicatingsupply vacuum to the probe to prolapse tissue) of the disposable probeassembly of FIG. 1;

FIG. 6 a longitudinal, horizontal cross sectional view through thevacuum assist valve assembly in a distally translated state (i.e.,communicating increased pressure such as atmospheric pressure to theprobe) of the disposable probe assembly of FIG. 1;

FIG. 7 is a longitudinal, horizontal cross sectional view viewed frombelow through a saline flush valve assembly in an initial, retractedstate (i.e., communication allowed between center port of the vacuumassist valve assembly and the probe) of the disposable probe assembly ofFIG. 1;

FIG. 8 is a longitudinal, horizontal cross sectional view viewed frombelow through the saline flush valve assembly in a distally translatedstate (i.e., communication allowed between a saline supply conduit andthe probe) of the disposable probe assembly of FIG. 1;

FIG. 9 is a left isometric view from above of the reusable hand piece ofFIG. 1 with the handle housing shown in phantom to expose the dualcarriages distally translated;

FIG. 10 is a right isometric view from below of the reusable hand pieceof FIG. 9 with the handle housing shown in phantom;

FIG. 11 is a left isometric exploded view from below of the reusablehand piece of FIG. 1;

FIG. 12 is a left isometric view from slightly below the reusable handpiece with the handle housing removed to expose the distally positioneddual carriages and a portion of the disposable probe assembly installedwith a generally rectangular cover removed;

FIG. 13 is a bottom view taken along a horizontal cross section throughthe probe of an assembled biopsy device of FIG. 1 with dual carriagesboth distally positioned;

FIG. 14 is a left isometric detail view of the dual carriages inopposite translations as initially positioned during engagement of thedisposable probe assembly and during insertion into tissue;

FIG. 15 is a bottom view taken in horizontal cross section through alead screw of the reusable hand piece of FIG. 14;

FIG. 16 is a left isometric view of portions of the biopsy device ofFIG. 1 depicted to include the dual carriages in the initial positionand sleeve union in phantom and also depicted with the probe andpneumatic components of the disposable probe assembly;

FIG. 17 is a left isometric view from below the portions of the biopsydevice of FIG. 16 after retraction of the distal carriage;

FIG. 18 is a bottom isometric view of the frame and dual carriageportion of the biopsy device of FIG. 1 with a horizontal portion cutawaymade through the pneumatic components of the engaged disposable probeassembly with valving positioned such that vacuum is communicated to thelateral lumen;

FIG. 19 is a bottom isometric view of the frame and dual carriageportion of the biopsy device of FIG. 1 with a horizontal portion cutawaymade through the pneumatic components of the disposable probe assemblywith valving positioned such that atmospheric pressure is communicatedto the lateral lumen;

FIG. 20 is a left side view of the probe assembly of the biopsy deviceof FIG. 1 taken in longitudinal cross section exposing a cutter tubedistally positioned after severing a tissue sample being retracted byvacuum assistance;

FIG. 21 is a left isometric view of portions of the biopsy device ofFIG. 1 depicted to include the dual carriages in a distal position forsaline flush and sleeve union in phantom and also depicted with theprobe and pneumatic components of the disposable probe assembly; and

FIG. 22 is a bottom isometric view of the frame and dual carriageportion of the biopsy device of FIG. 1 with a horizontal portion cutawaymade through the pneumatic components of the engaged disposable probeassembly with valving positioned such that saline is communicated to thelateral lumen.

DETAILED DESCRIPTION OF THE INVENTION

In FIGS. 1-2, a biopsy device 10 has a reusable hand piece 12 and adisposable probe 14 that enables economical taking of multiplepercutaneous core biopsy samples by accessing a standard medical vacuumpump or wall-mounted vacuum access port (not shown) through aninterfacing vacuum conduit 16. In addition, the biopsy device 10advantageously incorporates a saline flush capability received fromsaline supply conduit 17. In the illustrative version, the reusable handpiece 12 is self-powered and suitable for use in conjunction withultrasonic diagnostic imaging. The disposable probe 14 reduces theportion of biopsy device 10 that requires protective packaging to avoidcontact with sharp surfaces and to keep it sterile prior to use. Furthereconomy is accomplished by reducing the portion of the biopsy device 10that is disposed as medical waste between uses. Movable components ofthe disposable probe 14 are advantageously locked until mounted in anaccess trough 18 formed in a handle housing 20 of the reusable handpiece 12. It should be appreciated that one or more standard mechanical,pneumatic, or electrical latches (not shown) may be integrated into thebiopsy device 10 to secure the disposable probe 14 to the reusable handpiece 12.

In FIGS. 1-4, the disposable probe assembly 14 includes a substantiallyrectangular cover 22 sized to close the access trough recess 18 (FIGS.1-2). An end slot 24 formed in the cover 20 (FIGS. 1-2, 5-6) is closedby a probe union sleeve 26 attached to an inner surface 27 (FIG. 1) ofthe substantially rectangular cover 22. A core biopsy needle (“probe”)assembly 28 passes longitudinally through the probe union sleeve 26 andis formed by a probe tube 30 that includes an underlying lateral(vacuum) lumen 32 that communicates with a side aperture 34 (FIG. 1) viaholes 35 (FIG. 4) near a distal opening 36 of the probe tube 30 that isclosed by a piercing tip 38. A cutter tube 40 is sized to closely fitand translate within an inner diameter (i.e., cutter lumen) of the probetube 30 with a length sufficient to close the side aperture 34 with aproximal end 42 extending from the probe union sleeve 26 to attach to acutter gear 44, as depicted in FIG. 1.

It should be appreciated that the probe tube defines first and secondfluid passages that are separated longitudinally within the probe tubeand distally communicate with each other at the side aperture 34. In theillustrative version, the first fluid passage is defined within thecutter tube 40 and the second fluid passage is defined within thelateral lumen 32 that is “hard walled” apart from a cylindrical portionof the cutter lumen of the probe tube 35. However, for a cylindricalprobe tube (not shown), a cutter tube may be axially offset within thecutter lumen of the probe tube such that the cutter tube may separatethe first and second fluid passages, especially if the cutter tube neednot be retracted for retraction of samples (e.g., vacuum retraction,straw retraction, single sample per insertion devices).

With particular reference to FIG. 3, sample retrieval tube 46 isreceived within a proximal opening in the cutter gear 44 and in turnproximally terminates itself at a half cylinder connector 47 positionedproximate to a rear support bracket 49 attached to the generallyrectangular cover 22. As described in the cross referenced applicationSer. No. 11/198,558, the half cylinder connector 47 attaches to a movingportion of a sample holding apparatus and the rear support bracket 49attaches to a stationary portion of the sample holding apparatus(proximal sample stacker 48). The relative movement increments a capturemechanism as samples are proximally stacked with vacuum being portedthrough the half cylinder connector 47 and sample retrieval tube 46 toextract samples from the cutter tube 40.

With continued reference to FIG. 3, proximal to the probe union sleeve26 is an elongate slot 50 that is part of a vacuum assist valve assembly52. The cutter gear 44 includes distal and proximal annular recesses 54,56 flanking spur gear teeth 58 that engage the reusable hand piece 12 asdescribed below. A more distal annular recess 60 is gripped by a firstvalve post 62 that is engaged to longitudinally translate in an elongatepost slot 64 of a distal portion 66 of a vacuum valve actuator 68.

In FIGS. 3, 5, a cylindrical proximal portion 70 of the vacuum valveactuator 68 has distal and proximal O-ring grooves 72, 73 thatrespectively retain distal and proximal dynamic O-ring seals 74, 75 thatmove within a distally open cylindrical valve bore 76 of a vacuum valvebody 78 molded onto an outer surface 79 of the substantially rectangularcover 22.

In an initial state depicted in FIG. 5, the vacuum valve actuator 68 isin a retracted position (along with the cutter tube 40), allowingcommunication between a proximal vacuum port 80 and a center vacuum port82. In FIG. 6, distal translation of the vacuum valve actuator 68enables communication between the center vacuum port 82 and a distalvacuum port 84. The center vacuum port 82 is attached to a proximal endof a distal vacuum conduit 86 whose other distal end is connectedthrough the rectangular cover 22 to the probe union sleeve 26 (FIGS.2-3). It should be appreciated that the probe union sleeve 26 includesfluidic passages that communicate between the proximal end of the vacuumlumen 32 and the distal vacuum conduit 86 as allowed by the saline flushvalve assembly 87 (FIG. 7).

Returning to the vacuum assist valve assembly 52 of FIGS. 2-3, 5-6, thedistal vacuum port 84 is attached to a hose nib 88 that is exposed toatmospheric pressure. Hose nib 88 may include an air and/or salinefilter. Alternatively, hose nib 88 may be connected to a positivepressure source (e.g., fluid pump) or a negative pressure source (e.g.,vacuum pump, syringe) to aspirate fluids. Likewise, hose nib 88 may beused to lavage the tissue cavity with saline, pain medication, orbleeding control fluids. The proximal vacuum port 80 communicatesthrough a proximal vacuum conduit 90 to the interfacing vacuum conduit16.

In FIGS. 2-3, 7-8, the flush valve assembly 87 includes a proximallyopen saline valve bore 92 formed in a saline valve body 94 molded ontothe outer surface 79 of the substantially rectangular cover 22 distal toa laterally offset longitudinal slot 96 (FIG. 3) defined in a distalportion of the substantially rectangular cover 22.

With particular reference to FIGS. 3, 7, a saline valve actuator 98includes a distal cylindrical spool 100 that is sized to be slidinglyreceived within the proximally open saline valve bore 92. A distalO-ring groove 102 that receives a distal saline O-ring 104 and amid-shaft O-ring groove 106 that receives a mid-shaft saline O-ring 108are spaced on the distal cylindrical spool 100 to selectively allowcommunication between a proximal saline port 110, which is attached tothe distal end of the distal vacuum conduit 86, and a center moldedconduit 112 that communicates through the probe sleeve union 26 to thevacuum lumen 32 when the saline valve actuator 98 is proximallypositioned, as depicted in FIG. 7. When the saline valve actuator 98 isdistally positioned, as depicted in FIG. 8, the center molded conduit112 communicates with a distal saline port 114 that is attached to aproximal end of the saline supply conduit 17. A proximal end of thesaline valve actuator 98 is attached to a saline slot link 116 thatlongitudinally slides within the laterally offset longitudinal slot 96extending a proximal carriage engagement member 118 out of the innersurface 27 of the substantially rectangular cover 22.

With reference to FIGS. 1-2, 9-11, the reusable hand piece 12, asdescribed in previously cross referenced U.S. patent application Ser.No. 11/198,558 includes four user controls aligned on a top surface 160of the housing 20, specifically from most distal to most proximal: aforward motor rotation key 162, a reverse motor rotation key 164, asaline flush key 166 and a slide button 168 for selecting insertion modeor sample taking mode. The keys 162-166 control a control circuit 170,which may include integral power storage (e.g., batteries, fuel cell,etc.) for untethered use. With particular reference to FIG. 11, theforward motor rotation key 162 causes a DC motor 172 to rotate its motoroutput shaft 174 in a forward rotation. A slide spur gear 176 includesan internal keyed engagement with a longitudinal key groove 178 on themotor output shaft 174 that allows longitudinal positioning by the slidebutton 168. In particular, fore and aft brackets 180, 182 of the slidebutton 168 engage distal and aft annular grooves 184, 186 that flankspur gear teeth 188 of the slide spur gear 176.

When the slide button 168 is moved distally, the slide spur gear 176engages a tissue penetration gear 190 that spins on a common shaftcenterline 192 forward of a gearbox input gear 196. Gearbox input gear196 consists of a distal small gear 198 and a proximal large gear 200.The tissue penetration gear 190 has spur gear teeth 206 that engage theslide spur gear 176. A frame post 212 projects proximally from an aftwall 234 of a frame 204 with a strike pin 214 projecting upwardly fromthe frame post 212. In FIGS. 11-12, a circular cam wheel 216 is attachedto a distal side of the tissue penetration gear 190. Rotating the tissuepenetration gear 190 urges the strike pin 214, and thus the frame 204,proximally. In FIGS. 11, 13, left and right spring cavities 218, 220(when viewed from above), formed longitudinally in distal corners of theframe 204, respectively receive inwardly projecting left and right tabs222, 224 (FIG. 13) from the cover 20 and receive left and rightcompression springs 226, 228. In particular, a distal end of eachcompression spring 226, 228 presses against a distal inner surface ofthe respective spring cavity 218, 220. A proximal end of eachcompression spring 226, 288 is grounded against a respective tab 222,224 of the cover 20. Thus, the frame 204 is biased distally within thecover 20. Movement of the frame 204 proximally compresses thesecompression springs 226, 228 that thereafter assert a restoring force.

When the slide button 168 is moved proximally, the slide spear gear 176is moved into engagement with the gearbox input gear 196, specificallythe distal small gear 198, which engages and turns a translation largeinput gear 230 whose shaft 232 passes through the aft wall 234 of theframe 204. The proximal large gear 200 of the gearbox input gear 196engages and turns a rotation small input gear 236 whose shaft 238 passesthrough the aft wall 234. The frame 204 includes a carriage recess 240,defined between a partition 242 and the aft wall 234. The carriagerecess 240 contains longitudinally aligned left side lead (translation)screw 244 and right-side rotation spur gear 246 that are attached forrotation respectively with the shafts 232, 238. The partition 242 ispositioned aft of the left and right tabs 222, 224 of the cover 20 andalso defines in part the left and right spring cavities 218, 220.

The rotation spur gear 246 engages the cutter gear 44 when thedisposable probe 14 is inserted, imparting a rotation as the cutter tube40 and cutter gear 44 translate longitudinally in response to therotation of the lead (translation) screw 244. This translation is causedby lead screw threads 248. In particular, a distal carriage (cuttercarriage) 250 is longitudinally moved on the lead screw threads 248.Distal and proximal J-hook extensions 252, 254 project downwardly fromthe distal carriage 250 to engage the distal and proximal annularrecesses 54, 56 of the cutter gear 44 (FIG. 3). Distal of the distalcarriage 250, a biasing spring 256 urges against the distal carriage250, which assists in engagement of the lead screw threads 248 with thedistal carriage 250.

In FIGS. 11, 14-15, a sliding pin 260 has a proximal carriage slidingpin retainer 266 attached to a proximal carriage 258. A shaft 264 of thesliding pin 260 also passes through a distal carriage sliding pinretainer 270 attached to the distal carriage 250. Sliding pin 260 has aproximal end 262 and a distal end 268 to prevent the sliding pin 260from disengaging from the carriage sliding pin retainers 266, 270. Asliding pin spring 272 resides on the sliding pin 260 and is constrainedat each end by carriage sliding pin retainers 266, 270.

With the components of the reusable handpiece 12 now introduced, asequence of use of the biopsy device 10 will be described. Thedisposable probe assembly 14 is installed into the reusable hand piece12. In so doing, the distal carriage 250 engages the cutter gear 44 toposition (translate) the cutter tube 40, initially in a distal positionas depicted in FIG. 12. During installation, the proximal carriage 258engages the proximal carriage engagement member 118 feature located onsaline slot link 116 that engages the proximal portion of the salinevalve actuator 98. A proximally stacking sample retrieving device 48 isattached to the disposable probe assembly 14 to provide a pneumaticvacuum bias to the cutter tube 40 and to hold retracted tissue samples.

With the biopsy device 10 assembled, the reusable handpiece 12 ismanipulated to insert the piercing tip 38 of the core biopsy needle(probe) assembly 28 into tissue. Penetration of dense tissue is assistedby moving the slide button 168 distally to a “tissue insertion mode”wherein the slide spur gear 176 engages the tissue penetration gear 190.Depression of the forward motor rotation key 162 turns these gears 176,190 causing the circular cam wheel 216 to turn against strike pin 214that creates proximal longitudinal motion of frame 204 and the attachedcore biopsy needle (probe) assembly 28 of approximately 0.1 inch at arotation rate of 7 cycles per second (FIG. 12). Left and rightcompression springs 226, 228 provide the restoring distal longitudinalmotion to frame 204 and probe assembly 28 as left and right compressionsprings 226, 228 are repeatedly compressed between the distal surface ofthe left and right spring cavities 218, 220 of the frame 204 and theleft and right tabs 222, 224 of the housing 20. The restoring distallongitudinal motion to frame 204 and core biopsy needle (probe) assembly28 result in a corresponding distal motion of piecing tip 38 thatassists in penetrating tissue.

With the probe assembly 28 positioned, the slide button 168 is movedproximally to move slide spur gear 176 into engagement with the gearboxinput gear 196. Depression of the reverse motor rotation key 164 causesthe distal carriage 250 to retract (FIG. 17). Thereby, the vacuum assistvalve assembly 52 (FIG. 5) communicates vacuum through saline flushvalve assembly 87 (FIG. 7) of the disposable probe assembly 14 (FIG. 18)through the vacuum lumen 32 to a now open side aperture 34 in the probetube 30 (FIG. 4) to prolapse tissue. Vacuum is maintained by a lowerpressure also communicating through the cutter tube 40 through theproximal sample stacker 48. Depression of the forward motor rotation key162 (FIG. 1) distally translates the distal carriage 250 and thus thecutter tube 40 to sever a tissue sample (FIG. 20) as well as shiftingthe vacuum assist valve assembly 52 to a distal position (FIG. 6) thatcommunicates an increased pressure (e.g., atmosphere) through the salineflush valve assembly 87 (FIG. 7) through the vacuum lumen 32 to the sideaperture 34, allowing the vacuum through the cutter tube 40 to retractthe tissue sample (FIG. 20).

At this point or after subsequent sample taking cycles, the surgeon myelect to flush tissue debris or coagulated blood from the vacuum lumen32, side aperture 34 and cutter tube 40 of the probe assembly 28. Byfurther depression of the forward motor rotation key 162, the distalcarriage 250 advances slightly forward, drawing the proximal carriage258 onto the lead screw threads 248, and thereafter the distal carriage250 free wheels. Thereby, the flush valve assembly 87 switches frompneumatically coupling the lateral lumen 32 to the vacuum assist valveassembly 52 to coupling the saline supply (not shown) to the vacuumlumen 32. Thereby, the vacuum drawn through the cutter tube 40 causessaline (or other liquid provided) to be drawn through the vacuum lumen32 and into a distal end of the cutter tube 40 and out of the disposableprobe assembly 14, through proximal sample stacker 48 and then into thefluid collection canister (not shown) located near the vacuum pump. Whenthe proximal carriage 250 is not fully distal, the flush valve 87 ispositioned proximal of its fully distal position and prevents salinefrom communicating with the lateral lumen 32 of the probe assembly 28.

Control implementation may include sensing of the position of the distalcarriage 250 such that motor operation stops distal travel of the distalcarriage 250 prior to distal translation of the proximal carriage 258,requiring release of the forward motor rotation key 162 prior toactuating again to indicate a desire for saline flush. Alternatively, aseparate override button (not shown) may be used that continues forwardrotation of the lead screw 244 to effect the saline flush feature.

It should be appreciated that in the illustrative version, the distalcarriage 250 does not freewheel in its proximal-most position. Instead,rotation of the motor is stopped as the distal carriage 250 is about tocontact the proximal carriage 258 with closed-loop control based on anencoder (not shown) coupled to the DC motor 172 enabling accuratepositioning of the motor output shaft 174. Alternatively, freewheelingmay be incorporated at the proximal-most position of the distal carriage250 by adding a section of no helical threads to the proximal end of thelead (translation) screw 244 equal to the longitudinal thickness of thedistal carriage 250.

By virtue of the foregoing, with one-handed operation, a clinician isable to select between a plurality of ports (e.g., vacuum pressure,atmospheric pressure, saline supply) that can communicate with a sideaperture 34 of a needle assembly 28 of core biopsy device 10. Inparticular, valve mechanisms are contained on the hand piece that needonly selectively port a constant vacuum source without the necessity fora separate, expensive programmed control module. One advantage of suchan economical capability is providing “on-demand” saline flush to theside aperture 34 (or distal opening) of the needle assembly 28. Duringnormal tissue sampling, the side aperture 34 pressure levels transitionsfrom vacuum during cutting to atmospheric pressure while the tissuesample is being transported proximally out of the reusable handpiece 12.Clearing tissue debris from the needle assembly 28 at the press of asaline push key 166 during the sample ensures proper operation so thatthe desired number of samples may be taken.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein, will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the spirit and scope of the appendedclaims. Additionally, each element described in relation to theinvention may be alternatively described as a means for performing thatelement's function.

For example, one or more sensors may be incorporated into the hand piece12 to sense the actual position of each carriage or to sense theparticular disposable probe assembly assembled into the hand piece 12.

As another example, use of a proximal carriage for saline flush takesadvantage of this additional motive device that is dedicated for sampleretrieval in other versions of the disposable probe assembly (i.e.,straw). In some applications consistent with the present invention wheretwo carriages are not required or desired, an alternative saline valveselection may be incorporated where a separate electromechanical valveactuator may be incorporated that is not driven by the lead screw.

As an additional example, biasing the cutter tube 40 with a vacuumsource advantageously assists in both prolapsing tissue as well asretracting tissue samples from the probe assembly 28. However,applications consistent with the present invention may include reversingthe direction of fluid flow through the cutter tube and out of thelateral lumen 32. In addition, prolapsing of tissue may be alternativelyachieved by closing the lateral lumen and allowing the vacuum biasthrough the cutter tube 40 to effect tissue prolapse. In addition, apressurized liquid source may be directed by the flush valve assembly toforcibly push out a tissue sample or debris without the assistance of avacuum bias on the cutter tube.

As yet a further example, while the illustrative versions advantageouslyutilize a single motor and a single lead screw to translate twocarriages, applications consistent with aspects of the present inventionmay use two motors and two lead screws or one motor selectively coupledto one of two lead screws, each having a carriage.

As yet an additional example, while selective depression of the salinepush key 166 provides clinical flexibility, it should be appreciatedthat the dual carriage lends itself to alternatively mechanizingautomatic saline flush after each cutting cycle.

1. A biopsy device, comprising: a. a needle comprising a probe tube having a sample aperture; b. a cutter tube received in the probe tube for relative axial translation across the sample aperture to sever tissue prolapsed therein, a first fluid passage defined within the cutter tube and a second fluid passage defined between an outer surface of the cutter tube and an inner surface of the probe tube, wherein the cutter tube is operable to translate axially; c. a flush control; d. a flush valve assembly responsive to the distally positioned cutter tube and to an activation of the flush control to couple a selected one of the first and second fluid passage to a liquid source, wherein the other one of the first and second fluid passage is maintained at a lower pressure to the liquid source to effect fluid through the needle; e. a vacuum assist valve assembly responsive to an at least partially retracted longitudinal position of the cutter tube to couple a selected one of the first and second fluid passage to a pneumatic source, wherein the vacuum assist valve assembly further comprises a valve body comprising a distally open cylinder body, a first port distally positioned, a second port positioned proximal to the first port, and a third port positioned between the first and second port; and f. a vacuum valve actuator having distal and proximal dynamic seals spaced to encompass the first and third ports when distally positioned and the second and third ports when proximally positioned.
 2. The biopsy device of claim 1, wherein the probe tube further comprises a cylindrical cutter lumen attached to and in distal fluid communication with a lateral lumen defining the second fluid passage.
 3. The biopsy device of claim 1, further comprising: a. a cutter gear proximally attached to the cutter tube; b. a lead translation screw longitudinally aligned with the translation of the cutter gear; and c. a first carriage longitudinally translated by rotation of the lead screw engagable to a proximal portion of the cutter tube.
 4. The biopsy device of claim 3, further comprising a second carriage engaged to the lead screw proximal to the first carriage, the lead screw further comprising a distal nonengaging portion enabling free wheeling of the first carriage, wherein the first carriage is operable to draw the second carriage onto an engaging portion of the lead screw, the second carriage engaged to the flush valve assembly.
 5. The biopsy device of claim 3, further comprising a rotation spur gear engaged to the cutter gear during translation for imparting a rotation to the cutter tube.
 6. The biopsy device of claim 5, further comprising a motor driven gearbox operatively configured to turn the translation lead screw and the rotation spur gear at a fixed ratio.
 7. The biopsy device of claim 1, wherein the first port is connectable to a first pressure source, the second port is connectable to a second pressure source having lower pressure than the first pressure source, the third port is in communication with a vacuum lumen conduit, and the vacuum valve actuator is operatively configured to place the first port into communication with the third port during at least a portion of proximal translation of the cutter tube and to place the second port into communication with the third port during at least a portion of distal translation of the cutter tube.
 8. A biopsy device, comprising: a. a probe assembly, comprising: i. a probe support structure, ii. a probe tube attached to the probe support structure and having a side aperture, iii. a cutter tube slidingly received by the probe tube and sized to translate across the side aperture, iv. a first fluid passage defined within the cutter tube and a second fluid passage defined between an outer surface of the cutter tube and an inner surface of the probe tube, v. a pneumatic conduit connectable between a vacuum source and a proximal end of the probe tube communicating with a selected one of the first and second fluid passages, and vi. a flush valve assembly operatively configured to selectively communicate between a fluid source and the proximal end of the probe communicating with the other one of the first and second fluid passages; and b. a hand piece, comprising: i. a hand piece support structure having a lateral engaging portion operatively configured to receive the probe assembly, ii. a lead screw for cutter translation attached for rotation to the hand piece support structure, iii. a first carriage longitudinally translated by rotation of the lead screw and having an engagement member positioned to engage a proximal portion of the cutter tube, and iv. a second carriage, wherein the second carriage engages the lead screw proximal to the first carriage, the lead screw further comprising a distal nonengaging portion enabling free wheeling of the first carriage.
 9. The biopsy device of claim 8, wherein the probe tube further comprises a cylindrical cutter lumen attached to and in distal fluid communication with a lateral lumen defining the second fluid passage.
 10. The biopsy device of claim 8, wherein the probe assembly further comprises a cutter gear attached to the proximal portion of the cutter tube, the hand piece further comprising a rotation spur gear aligned to engage the cutter gear during longitudinal translation of the first carriage.
 11. The biopsy device of claim 10, wherein the hand piece further comprises a motor and a gearbox operatively configured to turn the translation lead screw and the rotation spur gear when the gearbox is driven by the motor.
 12. The biopsy device of claim 8, further comprising a vacuum assist valve assembly, comprising: a. a vacuum assist valve body comprising first, second and third ports, the first port connectable to a first pressure source, the second port connectable to a second pressure source having lower pressure than the first pressure source, the third port in communication with the other one of the first and second fluid passage; and b. a vacuum assist valve actuator coupled to the first carriage and operatively configured to place the first port into communication with the third port during at least a portion of proximal translation of the cutter tube and to place the second port into communication with third port during at least a portion of distal translation of the cutter tube.
 13. The biopsy device of claim 12, wherein the second carriage is longitudinally translated by rotation of the lead screw and positioned to engage for movement the flush valve assembly of the probe assembly, wherein the flush valve assembly further comprises: a. a flush valve body comprising first, second and third ports, the first port connectable to the fluid source, the second port connectable to the vacuum assist valve assembly, the third port in communication with the vacuum lumen conduit; and b. a flush valve actuator coupled to the second carriage and operatively configured to place the first port into communication with the third port during at least a portion of the proximal translation of the second carriage and to place the second port into communication with the third port during at least a portion of distal translation of the cutter tube.
 14. The biopsy device of claim 8 further comprising a vacuum assist valve assembly comprising: a. a vacuum assist valve body attached to the probe support structure having a distally open cylinder body having a first port distally positioned, a second port positioned proximal to the first port, and a third port positioned between the first and second port; and b. a vacuum valve actuator having distal and proximal dynamic seals spaced to encompass the first and third ports when distally positioned and the second and third ports when proximally positioned.
 15. The biopsy device of claim 8, wherein the hand piece further comprises a spring biased member reciprocatingly cammed to impart a longitudinal reciprocating motion to the probe during insertion.
 16. A biopsy device, comprising: a. a probe assembly, comprising: i. a probe support structure, ii. a probe attached to the probe support structure and having a side aperture, iii. a cutter tube slidingly received by the probe and sized to translate across the side aperture, iv. a lateral lumen of the probe communicating with the side aperture, v. a pneumatic conduit connectable between a vacuum source and a proximal end of the cutter tube, and vi. a tissue sample retraction mechanism; and b. a hand piece, comprising: i. a hand piece support structure having a lateral engaging portion operatively configured to receive the probe assembly, ii. a lead screw for cutter translation attached for rotation to the hand piece support structure, iii. a first carriage longitudinally translated by rotation of the lead screw and having an engagement mechanism positioned to engage a proximal portion of the cutter tube, and iv. a second carriage longitudinally translated by rotation of the lead screw and positioned to engage for movement the tissue sample retraction mechanism.
 17. The biopsy device of claim 16, wherein the tissue sample retraction mechanism of the probe assembly comprises a proximal stacker operatively configured to pneumatically retract tissue samples through the cutter tube.
 18. The biopsy device of claim 16, wherein the tissue sample retraction mechanism of the probe assembly comprises a straw assembly reciprocally inserted through the cutter tube to retract tissue samples.
 19. The biopsy device of claim 16, wherein the probe assembly further comprises a vacuum assist valve assembly operatively configured to selectively communicate the vacuum source to the lateral lumen.
 20. A biopsy system for performing a core biopsy procedure, comprising: a. a static vacuum source; b. a fluid supply; and c. a hand-held device, comprising: i. a core biopsy probe comprising a cutter lumen having a distal sample aperture, ii. a housing proximally attached to the core biopsy probe and sized to be manually held for positioning the core biopsy probe, iii. a fluid input attached to the housing and attachable to the fluid supply, iv. user controls attached to the housing, v. a motorized cutter translated in the cutter lumen of the core biopsy probe in response to the user controls, vi. a valve assembly responsive to the user controls to selectively communicate the fluid input to the core biopsy probe, vii. a lead screw for cutter translation attached for rotation to the housing, viii. a first carriage longitudinally translated by rotation of the lead screw and having an engagement mechanism positioned to engage a proximal portion of the cutter, and ix. a second carriage longitudinally translated by rotation of the lead screw and positioned to engage for movement the valve assembly.
 21. The biopsy system of claim 20, wherein the hand-held device further comprises a pneumatic input attached to the housing and attachable to the static vacuum source, the core biopsy probe further comprising a vacuum lumen communicating with the distal sample aperture, the cutter lumen communicating with the static vacuum source, the valve assembly further responsive to a first position of the cutter to communicate static vacuum pressure to the vacuum lumen to prolapse tissue into the sample aperture, responsive to a second position of the cutter to communicate atmospheric pressure to the vacuum lumen to retract a severed tissue sample, and responsive to the user controls to communicate the fluid supply to the vacuum lumen. 